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Biosimilars Education: Addressing a significant unmet need

Biosimilars Education: Addressing a significant unmet need

  • November 2016
  • ID: 4699256
  • Format: PDF
  • By Firstword Pharma


Table of Contents


How to educate stakeholders about biosimilar benefits

What information and data do physicians, payers and patients need about biosimilars? benefits
As the market expands and new therapeutic sectors come on stream, more stakeholders will come into contact with biosimilars. Their information needs vary widely from a basic understanding of biosimilars to detailed scientific data. What educational programmes are required and how can biosimilar developers deliver the specific messages and knowledge that give physicians and patients’ confidence? benefits

Report Overview
To help you meet the educational challenges in the US and EU, leading industry experts and KOLs share their frontline knowledge in Biosimilars Education: Addressing a significant unmet need.

Report Features
- In-depth interviews reveal unique insights from the different perspectives of industry experts and clinical KOLs in the US and EU.
- Extensive examination of US and EU biosimilar regulatory and market environments
- Tables showing approved biosimilars in EU and US.
- Chart illustrating the role of stakeholders in improving biosimilar trust and confidence.
- Chart illustrating the 5 major biosimilar knowledge gaps.
- Survey chart showing responses as to how HCP’s want to access biosimilar information.
- Chart: Biosimilar education areas of focus.
- Chart: Comparative pathways to regulatory submission for traditional and biosimilar approaches.
- At-a-glance summaries of all the main insights.

Key Benefits
- Understand the different market conditions in the established EU market and fast developing US biosimilar sector.
- Appreciate the varying levels of physician knowledge and know what that means for education programme design.
- Know what is an appropriate level of information and support for patients.
- Review the biosimilar educational initiatives of organisations such as Amgen, Pfizer, Merck and the FDA.
- Respond to the anxieties of physicians who are newly dealing with biosimilar products that lack the wealth of trial and clinical data of originator therapies.
- Develop powerful educational programmes as part of your value added services and outreach.
- Plan to expand your post-marketing monitoring and use real world knowledge to enhance your clinical education.

Key Questions Answered By This Report
- Two-speed markets: The EU and US biosimilars markets are at very different stages of their evolution – what can be learnt from these diverse experiences?
- Listen, then speak: How can listening to stakeholders about the information they want – and how they want it – help to deliver on target education?
- Clinical confidence: How can you respond to physicians’ anxieties about using a biosimilar of which they have no experience or supporting data?
- Patient Information: What level of education should patients get and who should deliver it to them?
- Trust: How can you deliver your educational messages in a way that is trusted by physicians?
- Differentiation: How can innovative educational programmes help to differentiate your biosimilar product?

Expert Views
To ensure candid views were expressed, some expert names have been kept anonymous, but each has been selected for their experience and detailed current knowledge of the biosimilar space.

Industry experts interviewed:
- Dr Bert Liang Founding CEO of Pfenex Inc, a biosimilar development company. He was previously founder, Chairman and CEO of Tracon Pharma and founder and Chairman of Coronado Biosciences.
- Dr Virginia Acha, Executive Director – Research, Medical & Innovation, Association of the British Pharmaceutical Industry. Formerly she worked for Amgen as Director, Global Regulatory and R&D Policy – EMEA and at Pfizer working on policy development in science and innovation in healthcare.
- Matthew S. Jones Chief Commercial Officer, Dyadic International Inc, where he leads their strategic partnering, licensing and commercial activities. Formerly he worked for Lonza Biologics and Ricerca BioSciences LLP.
- Senior Medical Director, Top 25 biopharmaceutical company, EU
- Global Head of Medical Affairs, Top 10 biopharmaceutical company, EU

Key opinion leaders interviewed, all of whom are specialists in oncology:
- Key Opinion Leader, UK
- Key Opinion Leader, France
- Key Opinion Leader, US

4 Key Quotes
“Realising that physicians still need more information on what the biosimilar concept is about, we shifted back to the basics. Before overwhelming them with detailed study data, we really moved back to the basics to lay the foundations of general understanding, because it is a totally different concept to what physicians are used to with a new originator drug.”
Global Head of Medical Affairs, EU Biosimilar Company

“If you've got the safety and efficacy endpoint and you are a tenth of the price of the branded product, then that's a great place to be. Now it's about carefully adding extra value, for example around engaging with patients and helping them to adhere to their prescription. We invest heavily in patient engagement programmes around adherence. We think it's a very powerful reimbursement payer discussion to have if you have data that says we support our patients taking their medicines in the way that they have been prescribed. In the modern world that equates to social media and apps for iPads, iPhones and similar devices.”
Matthew Jones, Dyadic

“The more experienced physicians become using these biosimilars, and they understand that their experience is similar to that of our European colleagues, I think that's the key component that is going to allow for driving forward these medications, because one physician will educate another one as well.”
Dr Bert Liang, Biosimilars Council

“Doctors can't spend a lot of time, so get to the point that biosimilars are different in this way; they are just as safe; they are just as efficacious; and here's the potential cost-effectiveness benefit that you get from them.”
Key Opinion Leader, US

Who Would Benefit from This Report?
- Medical affairs teams supporting biosimilar market access
- HEOR professionals building evidence of biosimilar value
- MSL teams needing to demonstrate the safety and efficacy of biosimilars to physicians
- Marketing teams using educational initiatives within a biosimilar product’s offering
- Brand teams wanting to competitively differentiate their biosimilar in the market
- Competitive intelligence professionals monitoring competitor education initiatives
Post-marketing surveillance teams collecting real world data on clinical and patient biosimilar experience

Content Highlights
Executive summary
- Background and definitions
- What are biosimilars?

Biosimilars regulation
- Europe
- United States
- Biosimilars nomenclature
- Biosimilars market environment
- Europe
- United States
- Key reference products targeted by biosimilar developers

Biosimilars Education
- Understanding the gaps in educational programmes
- Surveys highlight major knowledge gaps and a lack of trust
- The content of biosimilars education: an industry perspective
- Back to basics: what are biosimilars and are they safe? An industry perspective
- What is a biosimilar and why is it not the same as a generic? An HCP perspective
- Physicians want to understand the development process
- Educating all stakeholders, not just physicians
- Patient access and support
- Patient awareness of biosimilars: an HCP perspective

A review of biosimilars education channels
- Biosimilars CME via online channels
- Biosimilars CME from the FDA
- Company online resources
- Alliance for Safe Biologic Medicines
- Collaborative biosimilar education initiatives
- Trends in biosimilars education delivery
- An industry perspective
- KOLs expect to be educated at medical meetings
- Stakeholders becoming proactive in biosimilars education delivery
- The biosimilars education maturity curve
- The importance of tailoring education to the audience
- An opportunity for US education to build on the experience in Europe
- Biosimilars will test the science as they enter the oncology setting
- Critical success factors for biosimilar education programmes

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